BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO PS FEMUR WAFFLE W/LFIT

    MDR report key: 1192790 · Received October 8, 2008

    Report

    Report Number
    2249697-2008-00301
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K962152
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. SHOULD DEVICE BECOME AVAILABLE WITH ADDITIONAL INFORMATION, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SCORPIO TOTAL KNEE IMPLANTED IN 2000. PRESENTED LOOSE AND PAINFUL W/LUCENCY AROUND CEMENT MANTLE OF FEMUR AND TIBIA. THE ABOVE IMPLANT (NO OTHER PART # OR LOT # INFOR IS KNOWN) WERE REMOVED AND A SCORPIO TS WAS IMPLANTED WITH THE FOLLOWING PARTS. 76-4105L LOT #1AHMPA SCORPIO TS LEFT FEMUR #5, 6476-8-260 LOT #HA113LAORC 80MM CEMENTED STEM, 75-1-0510 2 EA LOTS RK5MJD, T04V453 DISTAL FEMORAL BLOCKS #5 10MM, 77-4005 SCORPIO TIBIAL TRAY #5, LOT NMOMHE, 6767-08-260 STEM 80MM, LOT HA122LAORI, #72-4-0521 LOT 96HMND INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO PS FEMUR WAFFLE W/LFIT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention